- ICH GCP
- Rejestr badań klinicznych w USA
- Badanie kliniczne NCT00338832
Effectiveness of a Lifestyle Intervention for Increasing Physical Activity in Adults With Schizophrenia
Adapting a Physical Activity Intervention for Schizophrenia
Przegląd badań
Status
Warunki
Szczegółowy opis
Schizophrenia is a severely disabling brain disorder. People with schizophrenia often experience hallucinations, delusions, thought disorders, and movement disorders. Physical activity (PA) has been shown not only to increase quality of life, but also to reduce risk factors for several chronic diseases and conditions. The majority of adults, however, do not engage in the recommended amount of PA. Research has shown that people with schizophrenia are even less likely to be regularly physically active. Symptoms of schizophrenia, pharmacological treatments for the disease, and the lifestyle associated with the disease tend to contribute to physical inactivity and the resulting complications. Effective interventions to increase PA have been developed for the general adult population, but very little is known about how to adapt them for use in adults with schizophrenia. The PRIME (Physically Ready for Invigorating Movement Every Day) program is a lifestyle intervention focused on increasing physical activity. This study will evaluate the effectiveness of a modified PRIME program in reducing the risk for morbidity in sedentary adults with schizophrenia.
Participants in this 24-week, single-blind study will be randomly assigned to either the PRIME intervention group or the comparison group, which will involve the Program for Activity, Leisure Skills, and Socialization (PALSS). All participants will attend 90-minute sessions weekly for the first 16 weeks, then biweekly for the remaining 8 weeks. PRIME sessions will focus on learning about PA, setting PA-related goals, and assessing short- and long-term goals. Goals may include early-stage process-oriented goals, such as reading about PA benefits or finding a walking partner. Goals tailored to later stages of change include explicit PA goals, such as increasing frequency, duration, and intensity of PA. Training will also be accomplished online and via printed material. PALSS sessions will focus on motivating participants to engage in leisure and social activity. Sessions will include interactive, structured activity that will be led by a therapist, as well as unstructured leisure activities, such as board games, cards, general socialization, and viewing a travel video. Social and communication skills will not be explicitly taught or practiced. All participants will attend study visits at Months 2, 6, and 8 to assess outcomes. A follow-up visit will be held 2 months post-intervention.
Typ studiów
Zapisy (Rzeczywisty)
Faza
- Faza 3
Kontakty i lokalizacje
Lokalizacje studiów
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California
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La Jolla, California, Stany Zjednoczone, 92093
- University of California, San Diego
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Kryteria uczestnictwa
Kryteria kwalifikacji
Wiek uprawniający do nauki
Akceptuje zdrowych ochotników
Płeć kwalifikująca się do nauki
Opis
Inclusion Criteria:
- Speaks English
- Diagnosis of schizophrenia or schizoaffective disorder
- Currently living in a residential facility
- Currently receiving outpatient care
- Medical clearance
- Willing to sign a release of medical information
Exclusion Criteria:
- Inability to complete assessments
- Medical conditions that may make increasing physical activity unsafe
- Pregnant
- Currently participating in regular moderate to vigorous physical activity (defined as more than 150 minutes per week)
Plan studiów
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Leczenie
- Przydział: Randomizowane
- Model interwencyjny: Przydział równoległy
- Maskowanie: Pojedynczy
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
---|---|
Eksperymentalny: 1
Participants will receive the Physically Ready for Invigorating Movement Every Day program
|
The PRIME program is a lifestyle intervention focused on increasing physical activity.
The intervention is cognitive/behaviorally based, 24-weeks in length, and a lifestyle PA intervention known to be effective in the general population of adults.
The program has been modified based on theory and empirical findings about this special subgroup.
All participants will attend 90-minute sessions weekly for the first 16 weeks, then biweekly for the remaining 8 weeks.
PRIME sessions will focus on learning about PA, setting PA-related goals, and assessing short- and long-term goals.
Goals may include early-stage process-oriented goals, such as reading about PA benefits or finding a walking partner.
|
Aktywny komparator: 2
Participants will receive the Program for Activity, Leisure Skills, and Socialization
|
PALSS sessions will focus on motivating participants to engage in leisure and social activity.
Sessions will include interactive, structured activity that will be led by a therapist, as well as unstructured leisure activities, such as board games, cards, general socialization, and viewing a travel video.
Social and communication skills will not be explicitly taught or practiced.
All participants will attend 90-minute sessions weekly for the first 16 weeks, then biweekly for the remaining 8 weeks.
|
Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Ramy czasowe |
---|---|
Frequency and intensity of PA
Ramy czasowe: Measured at baseline and Months 2, 6, and 8
|
Measured at baseline and Months 2, 6, and 8
|
Miary wyników drugorzędnych
Miara wyniku |
Ramy czasowe |
---|---|
Quality of life
Ramy czasowe: Measured at baseline and Months 2, 6, and 8
|
Measured at baseline and Months 2, 6, and 8
|
Body mass index (BMI)
Ramy czasowe: Measured at Months 2, 6, and 8
|
Measured at Months 2, 6, and 8
|
Blood pressure
Ramy czasowe: Measured at baseline and Months 2, 6, and 8
|
Measured at baseline and Months 2, 6, and 8
|
Współpracownicy i badacze
Współpracownicy
Śledczy
- Główny śledczy: Laurie Lindamer, PhD, University of California, San Diego
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów
Zakończenie podstawowe (Rzeczywisty)
Ukończenie studiów (Rzeczywisty)
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Oszacować)
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Oszacować)
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Słowa kluczowe
Dodatkowe istotne warunki MeSH
Inne numery identyfikacyjne badania
- R34MH071539 (Grant/umowa NIH USA)
- DAHBR 96-BHB
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